FDA Device

Prostrate Seeding Applicator Needle. Product code PSS1820AT Packed in boxes of (25) with five Single Packs and four five packs or as singles or five packs. Worldwide Medical Technologies, LLC Used to introduce radionuclide seeds of 1-125 or Pd-103 into the body for radiation therapy. This device is typically used in the transperineal approach for placing radionuclide seeds in the prostate

Hazard

Length of the cannula hub is longer and may not permit a fit with the Applicator

What You Should Do

Remedy

BrachySciences, a division of Biocompatibles, Inc., sent out "Urgent Recall Device Recall" letters Dated August 12, 2011 to all affected customers. The letter included affected product and problem description. Customers are asked to quarantine and return unused product. A Product Recall & Retrieval Form was included to send back to the firm. For questions on this recall contact the firm at (203) 262-0571, extension 105.

Products

Prostrate Seeding Applicator Needle. Product code PSS1820AT Packed in boxes of (25) with five Single Packs and four five packs or as singles or five packs. Worldwide Medical Technologies, LLC Used to
Brand
Worldwide Medical Technologies, LLC
UPC
Product code PSS1820AT Lot 116261, Exp Date: 2016-06; and Lot 116589, Exp Date 2016-07

Units Affected

1872 units